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Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia

NCT00304993 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2006-03-21

No results posted yet for this study

Summary

Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome) are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle size, so often fenofibrate is added. This combination may still not be sufficient. Niacin is a common third drug added to the treatment regimen, but niacin can increase insulin resistance. This study compares niacin as a third drug to rosiglitazone, an insulin sensitizer.

Conditions

Interventions

DRUG

fenofibrate

DRUG

niacin

DRUG

rosiglitazone

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Kos Pharmaceuticals

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Foundation Research, Florida

    lead OTHER

Principal Investigators

  • Michael E McIvor, MD · Foundation Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-01-31
Completion
2005-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00304993 on ClinicalTrials.gov